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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00604 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases
PRIMARY OBJECTIVES:
I. To report the experience of SILS procedure in the treatment of colorectal disease.
II. To standardize the SILS technique.
OUTLINE:
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and at 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (single incision laparoscopic surgery) | Experimental | Patients undergo single incision laparoscopic surgery with GelPort® attachment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic laparoscopic surgery | Procedure | Undergo single incision laparoscopic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year |
| Length of skin and fascial incisions | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year |
| Estimated blood loss | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year |
| Oncologic sample including size of specimen removed, number of lymph nodes (LN) removed, pathological type and staging, lymph node, vessel or perineural invasion, and status of margins | Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data). | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | Baseline |
| Quality of life measured using the SF-12 HQRL scored using quality metric licensed software |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Renton, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Jamesline | View source |
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Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. |
| 2 weeks |
| Quality of life measured using the SF-12 HQRL scored using quality metric licensed software | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 3 months |
| Quality of life measured using the SF-12 HQRL scored using quality metric licensed software | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 6 months |
| Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | Baseline |
| Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 2 weeks |
| Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 3 months |
| Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 6 months |
| Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 2 weeks |
| Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 3 months |
| Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar" | Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated. | 6 months |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D003424 | Crohn Disease |
| D011125 | Adenomatous Polyposis Coli |
| D010580 | Peutz-Jeghers Syndrome |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D003108 | Colonic Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007911 | Lentigo |
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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